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The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

This study has been terminated.
(This study was terminated early in May 2006 due to low patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171431
First Posted: September 15, 2005
Last Update Posted: April 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.

Condition Intervention Phase
Constipation Predominant Irritable Bowel Syndrome (IBS-C) Drug: Tegaserod Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C
  • by using Multiple Intraluminal Impedance

Estimated Enrollment: 20
Study Start Date: November 2004
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female 18 and older
  • IBS-C patients diagnosed on the basis of Rome II criteria
  • Ability to comply with the requirements of the entire study

Exclusion Criteria:

  • Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
  • Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
  • Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171431


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171431     History of Changes
Other Study ID Numbers: CHTF919AUS33
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
IBS-C
female

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Tegaserod
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs